UIBC FOR DISCREET RANDOM ACCESS ANALYZER
FDA 510(k) clearance K932871 · decided 1993-09-08
Clearance details
- K-number
- K932871
- Device name
- UIBC FOR DISCREET RANDOM ACCESS ANALYZER
- Applicant
- Catachem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-14
- Decision date
- 1993-09-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- CFM
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bridgeport, CT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| SYNERMED SERUM IRON REAGENT KIT (K902918) | Synermed, Inc. | 1990-07-31 |
| CLINISTAT POTASSIUM REAGENT TEST (K895047) | Heraeus Kulzer, Inc. | 1989-10-17 |
| IRON REAGENT (K891155) | Medical Analysis Systems, Inc. | 1989-04-18 |
| ABBOTT A-GENT IRON REAGENT KIT (K873120) | Abbott Laboratories | 1987-08-25 |
| TOTAL IRON BINDING CAPACITY PROCEDURE (K861602) | Data Medical Associates, Inc. | 1986-05-23 |
| DART IRON & IRON BINDING CAPACITY REAGENT (K854305) | Coulter Electronics, Inc. | 1985-11-12 |
| DATA CHEM IRON PROCEDURE (K852583) | Data Medical Associates, Inc. | 1985-07-12 |
| SERUM IRON & SERUM IRON BINDING CAPACI (K842155) | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-07 |
Recalls involving this device
No recalls on record reference this clearance.